| CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
077170 |
001 |
ANDA |
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;120MG |
No
|
No
|
2008/02/25
|
2008/02/25
|
IVAX SUB TEVA PHARMS |
Over-the-counter |
| CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
077991 |
001 |
ANDA |
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;120MG |
No
|
No
|
2008/03/05
|
2008/03/05
|
PLD ACQUISITIONS |
Over-the-counter |
| FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
077999 |
001 |
ANDA |
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE; ORAL |
60MG; 120MG |
No
|
No
|
2010/02/25
(TA)
|
--
|
PLD ACQUISITIONS LLC |
None (Tentative Approval) |
| FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
079043 |
002 |
ANDA |
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
180MG;240MG |
No
|
No
|
2010/03/17
|
2011/06/22
|
DR REDDYS LABS LTD |
Over-the-counter |
| FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
079115 |
001 |
ANDA |
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE; ORAL |
60MG; 120MG |
No
|
No
|
2010/10/19
(TA)
|
--
|
WOCKHARDT |
None (Tentative Approval) |
| FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
076298 |
001 |
ANDA |
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
60MG;120MG |
No
|
No
|
2010/11/12
|
2010/11/12
|
IMPAX PHARMS |
Discontinued |
| CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
090922 |
001 |
ANDA |
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
5MG;120MG |
No
|
No
|
2012/09/28
|
2012/09/28
|
SUN PHARM INDS LTD |
Over-the-counter |
| HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
204627 |
001 |
ANDA |
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE |
SOLUTION;ORAL |
4MG/5ML;5MG/5ML;60MG/5ML |
No
|
Yes
|
2014/04/29
|
2014/04/29
|
PADAGIS US |
Prescription |
| HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
204658 |
001 |
ANDA |
HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML;60MG/5ML |
No
|
No
|
2014/04/29
|
2014/04/29
|
PADAGIS US |
Discontinued |
| BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE |
205292 |
001 |
ANDA |
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
SYRUP;ORAL |
2MG/5ML;10MG/5ML;30MG/5ML |
No
|
Yes
|
2014/07/15
|
2014/07/15
|
PADAGIS US |
Prescription |
| BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE |
202940 |
001 |
ANDA |
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
SYRUP;ORAL |
2MG/5ML;10MG/5ML;30MG/5ML |
No
|
No
|
2014/07/21
|
2014/07/21
|
PHARM ASSOC |
Prescription |
| HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
203839 |
001 |
ANDA |
HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML;60MG/5ML |
No
|
No
|
2014/10/28
|
2014/10/28
|
TRIS PHARMA INC |
Discontinued |
| FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
076667 |
001 |
ANDA |
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
60MG;120MG |
No
|
No
|
2014/11/18
|
2014/11/18
|
DR REDDYS |
Over-the-counter |
| HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
203838 |
001 |
ANDA |
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE |
SOLUTION;ORAL |
4MG/5ML;5MG/5ML;60MG/5ML |
No
|
No
|
2014/11/26
|
2014/11/26
|
TRIS PHARMA INC |
Discontinued |
| FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
090818 |
001 |
ANDA |
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
60MG;120MG |
No
|
No
|
2015/01/29
|
2015/01/29
|
SUN PHARM |
Over-the-counter |
| GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE |
091071 |
001 |
ANDA |
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
600MG;60MG |
No
|
No
|
2015/05/27
|
2015/05/27
|
ACTAVIS LABS FL |
Over-the-counter |
| GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE |
091071 |
002 |
ANDA |
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
1.2GM;120MG |
No
|
No
|
2015/05/27
|
2015/05/27
|
ACTAVIS LABS FL |
Over-the-counter |
| HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
205657 |
001 |
ANDA |
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE |
SOLUTION;ORAL |
4MG/5ML;5MG/5ML;60MG/5ML |
No
|
No
|
2015/08/03
|
2015/08/03
|
MAYNE PHARMA INC |
Discontinued |
| HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
205658 |
001 |
ANDA |
HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML;60MG/5ML |
No
|
No
|
2015/11/17
|
2015/11/17
|
MAYNE PHARMA INC |
Discontinued |
| BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE |
203375 |
001 |
ANDA |
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
SYRUP;ORAL |
2MG/5ML;10MG/5ML;30MG/5ML |
No
|
No
|
2016/09/20
|
2016/09/20
|
ACELLA |
Prescription |